The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400: Lipoproteins.
| Device ID | K060854 |
| 510k Number | K060854 |
| Device Name: | ABX PENTRA 400: LIPOPROTEINS |
| Classification | Calibrator, Secondary |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | JIT |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CHH |
| Subsequent Product Code | JJY |
| Subsequent Product Code | LBR |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-29 |
| Decision Date | 2006-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230007099 | K060854 | 000 |
| 03610230007044 | K060854 | 000 |
| 03610230005095 | K060854 | 000 |
| 03610230005743 | K060854 | 000 |
| 03610230005033 | K060854 | 000 |
| 03610230005019 | K060854 | 000 |
| 03610230004999 | K060854 | 000 |
| 03610230004975 | K060854 | 000 |